Wang Jin-Da, Yang Ting-Shu, Sun Zhi-Jun, Guo Jun, Tian Feng, Chen Yun-Dai
Department of Cardiology, Chinese PLA General Hospital, Beijing 100853, China.
Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2012 Feb;34(1):8-13.
To evaluate the safety and efficiency of local paclitaxel delivery using the double-balloon perfusion catheter to prevent restenosis in the canine coronary artery.
Twenty domestic canines underwent bare-mental stent implantation after balloon injure of the left coronary artery. A novel double-balloon perfusion catheter was used to deliver the drug locally in the canine coronary artery. In the treatment group (n = 15), paclitaxel (10 ml, 20 micromol/L) was delivered using the double-balloon perfusion catheter before stent implantation. In the control group (n = 5), 10 ml saline was delivered using the double-balloon perfusion catheter before stent implantation. The perfusion time in both groups was (26.45 +/- 5.18) s. Animals underwent coronary angiography and optical coherence tomography (OCT) 90 days after stent implantation and were sacrificed. Vessels were perfusion-fixed and morphometric analysis was performed using conventional techniques.
Coronary angiography results showed restenosis rate in control group was significantly higher than that in treatment group (60% vs. 33.33%, P < 0.05). The parameters of OCT showed in treatment group and control group: the neointimal thickness was (0.19 +/- 0.08) mm and (0.38 +/- 0.03) mm, the neointimal area was (1.52 +/- 0.49) mm2 and (2.51 +/- 0.47) mm2, the lumen area was (3.50 +/- 0.66) mm2 and (2.78 +/- 0.57) mm2, the extent of stenosis was (30.13 +/- 8.56)% and (47.40 +/- 4.50)%, and all the variances above were significantly different between the two groups (P < 0.05). The histologic parameters showed in treatment group and control group: the neointimal thickness was (0.22 +/- 0.10) mm and (0.47 +/- 0.05) mm, the neointimal area was (1.85 +/- 0.78) mm2 and (3.43 +/- 0.25) mm2, the lumen area was (3.15 +/- 0.43) mm2 and (1.85 +/- 0.55) mm2, the extent of stenosis was (36.00 +/- 10.97)% and (65.40 +/- 8.23)%, and all the variances above were also significantly different between the two groups (P < 0.05). The stents of both the groups were fully endothelialized. No thrombus or aneurysm was found in stents.
Local delivery of paclitaxel with the double-balloon perfusion catheter to prevent restenosis in coronary stents is safe and efficient.
评估使用双球囊灌注导管局部递送紫杉醇预防犬冠状动脉再狭窄的安全性和有效性。
20只家犬在左冠状动脉球囊损伤后接受裸金属支架植入。使用一种新型双球囊灌注导管在犬冠状动脉局部递送药物。治疗组(n = 15)在支架植入前使用双球囊灌注导管递送紫杉醇(10 ml,20 μmol/L)。对照组(n = 5)在支架植入前使用双球囊灌注导管递送10 ml生理盐水。两组的灌注时间均为(26.45 ± 5.18)秒。支架植入90天后对动物进行冠状动脉造影和光学相干断层扫描(OCT),然后处死动物。对血管进行灌注固定,并使用传统技术进行形态计量分析。
冠状动脉造影结果显示,对照组的再狭窄率显著高于治疗组(60% 对 33.33%,P < 0.05)。OCT参数显示,治疗组和对照组:新生内膜厚度分别为(0.19 ± 0.08)mm和(0.38 ± 0.03)mm,新生内膜面积分别为(1.52 ± 0.49)mm²和(2.51 ± 0.47)mm²,管腔面积分别为(3.50 ± 0.66)mm²和(2.78 ± 0.57)mm²,狭窄程度分别为(30.13 ± 8.56)%和(47.40 ± 4.50)%,上述所有差异在两组间均有统计学意义(P < 0.05)。组织学参数显示,治疗组和对照组:新生内膜厚度分别为(0.22 ± 0.10)mm和(0.47 ± 0.05)mm,新生内膜面积分别为(1.85 ± 0.78)mm²和(3.43 ± 0.25)mm²,管腔面积分别为(3.15 ± 0.43)mm²和(1.85 ± 0.55)mm²,狭窄程度分别为(36.00 ± 10.97)%和(65.40 ± 8.23)%,上述所有差异在两组间也有统计学意义(P < 0.05)。两组支架均完全内皮化。支架内未发现血栓或动脉瘤。
使用双球囊灌注导管局部递送紫杉醇预防冠状动脉支架再狭窄是安全有效的。